Duns Number:012430880
Device Description: Acclean Gentle Pick
Catalog Number
5701409
Brand Name
Henry Schein
Version/Model Number
5701409
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
JET
Product Code Name
PICK, MASSAGING
Public Device Record Key
f21d48c2-80a3-4362-9f99-1dc0f92236c9
Public Version Date
March 11, 2019
Public Version Number
1
DI Record Publish Date
February 07, 2019
Package DI Number
20304040108912
Quantity per Package
12
Contains DI Package
10304040108915
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 3829 |
2 | A medical device with a moderate to high risk that requires special controls. | 2579 |
3 | A medical device with high risk that requires premarket approval | 1 |
U | Unclassified | 34 |